Vaibhav Kumar, MSc

Validation Advisor

Vaibhav is a Quality leader, having gained exposure in the pharmaceutical industry for over 18 years. Vaibhav graduated with “Master’s in pharmacy in Pharmaceutical Chemistry” and a Licensed Industrial Pharmacist.

Vaibhav is a subject matter expert in Validation (process, cleaning, and hold time), Qualification (area, equipment, and utilities), Quality Management systems (deviation, change control, market complaint, OOS, OOT & CAPA management), Quality Risk Management related to process, equipment and facility, Vendor Qualification, Technology transfer and preparation of key documents such as Site Master File, Validation Master Plan & SOPs.

Vaibhav successfully faced and managed multiple regulatory audits – USFDA, EU-GMP, MHRA, TGA, ANVISA, GCC, WHO.

Vaibhav possesses in-depth knowledge in developing quality systems, policies, and procedures as per the regulatory guidelines. Vaibhav is committed to delivering training programs and GxP practices to build competency, skills, knowledge on current GxP requirements, and regulatory compliance.

Vaibhav is accustomed to working in a fast-paced, challenging environment for setting up the new manufacturing facility from design to commercialization, covering the project design, qualification of equipment, installation, operation and performance of utility and area, process and cleaning validation and providing support in procuring of equipment, utilities, and materials.

Vaibhav is a self-starter and complex problem solver who employs valuable leadership and communication techniques when working collaboratively with the team.

Address

Calgary, Canada